B5 Biosimilars for all: Research, regulation and responsible use

Organised by the FIP Hospital Pharmacy Section, the FIP Special Interest Group on Regulatory Sciences, the FIP Health and Medicines Information Section, the FIP Special Interest Group on Analytical Sciences and Pharmaceutical Quality and the FIP Special Interest Group on Biotechnology

Chairs: James Stevenson (University of Michigan, USA) and Michael Ward (University of South Australia, Australia)

Introduction

This session has been planned to meet the needs of pharmaceutical scientists and pharmacists in all practice settings with an interest in drug development, regulatory processes, new medicines, health care policy, law, medicines safety, pharmacovigilance and leadership.

With regard to the regulatory processes for biosimilars, several countries have developed their own guidelines for approval, including extrapolation of clinical data. There is a global challenge to adopt standard regulatory processes in order to provide needed access to these medicines across the world. This session will address the analytical characterisation, bioanalytical assay development for pharmacokinetic and immunogenicity assays and the regulatory perspectives on the advancement of biosimilar products. With the expansion of the use of biologics and the development of biosimilars, pharmacists must address the operational challenges and opportunities related to introducing biosimilars into the medicines use process.

The presenters in this session will discuss challenges in the regulatory process, the experience with biosimilars in the European Union and other regions, and key formulary, legal, policy, and operational factors to consider when integrating biosimilars into the medicines use process, including issues regarding interchangeability with reference products. Practical issues related to naming, pharmacovigilance and transitions of care will also be discussed.

Learning objectives

At the conclusion of this knowledge-based session, participants will be able to:

Describe the process for regulatory approval of biosimilars in various regions of the world and issues related to the approval process.

Explain the experience in the EU with biosimilars, including safety and management of issues such as indication extrapolation, uptake and pharmacovigilance.

State the key factors and decisions that must be considered in the formulary consideration of biosimilars.

Define factors that must be addressed in order to safely integrate biosimilars into the medicines use process, including those around naming and pharmacovigilance.

Programme

09:00 – 09:10

1. Introduction by chairs

09:10 – 09:50

2. Challenges and lessons learnt in the regulatory approval process for biosimilars

Vinod Shah (Pharmaceutical Consultant, USA)

09:50 – 10:20

3. Understanding the similarity exercise: the basis for biosimilar acceptance